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The future of Roche AG’s cancer treatment Avastin has been left at the hands of US drug regulators amid concerns over its benefits for advanced breast cancer patients.
A review of the drug on Friday revealed that the benefits of the blockbuster drug may not outweigh the risks for patients after two recent studies of the drug failed to show the same level of benefit for advanced breast cancer patients as had been witnessed in earlier trials.
The US Food and Drug Administration (FDA) will now review the data on Tuesday before deciding the future of the top-selling drug.
Concerns over the future of the drug have had a ripple effect on international markets, with investors spooked enough to knock the manufacturer’s stock down 4% ahead of a final ruling over the marketing of Avastin later this week.
While the ruling could see the drug pulled as a treatment option for advanced breast cancer, it could still be prescribed by doctors as it has also been approved for other cancers.
Analysts at Berenberg Bank in the US said there was a “significant probability” that the drug’s breast cancer indication would be withdrawn.
Copyright Press Association 2010
US Food and Drug Administration
